Duplaxil 200 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Duplaxil 200 mg film-coated tablets EFG

Hydroxychloroquine sulfate

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.

  • If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Duplaxil is and what it is used for
2. What you need to know before taking Duplaxil
3. How to take Duplaxil
4. Possible side effects
5. How to store Duplaxil
6. Contents of the pack and other information

1. What Duplaxil is and what it is used for

Duplaxil contains the active substance hydroxychloroquine sulfate.

It can be used for:

Adults

• The treatment of a chronic disease causing inflammation of the joints, muscles, tendons, or ligaments (rheumatoid arthritis).
• Certain diseases which manifest, among other symptoms, as skin or joint problems (discoid and systemic lupus erythematosus).
• The treatment of skin disorders associated with sensitivity to sunlight (photosensitivity dermatoses).
• The treatment of acute episodes of malaria and for prevention of malaria.

Children (6 years of age or older and weighing 31 kg or more)

• The treatment of juvenile rheumatism in combination with other treatments (juvenile idiopathic arthritis).
• Certain diseases which manifest, among other symptoms, as skin or joint problems (discoid and systemic lupus erythematosus).
• The treatment of acute episodes of malaria and for prevention of malaria.

2. What you need to know before taking Duplaxil

Do not take Hydroxychloroquine if:

• You are allergic to:
  • hydroxychloroquine sulfate or any of the other ingredients of this medicine (listed in section 6).
  • other similar medicines such as quinolones and quinine (other medicines used for malaria).
• You have certain eye problems (maculopathy or retinitis pigmentosa).
• You suffer from a specific form of muscle weakness (myasthenia gravis).
• Hydroxychloroquine must not be used in children under 6 years of age and weighing less than 31 kg.

If any of the above conditions apply to you, do not take this medicine. If you are unsure, consult your doctor or pharmacist before starting hydroxychloroquine.

Warnings and precautions

Talk to your doctor or pharmacist before starting hydroxychloroquine:

• If you have liver or kidney problems.
• If you suffer from serious stomach or intestinal disorders.
• If you are taking a medicine called tamoxifen, used to treat breast cancer.
• If you have any blood disorders. You may need blood tests to monitor this.
• If you have heart problems (symptoms include difficulty breathing and chest pain), which may require monitoring.
• If you have any disorders of the nervous system or brain.
• If you suffer from psoriasis (red, scaly patches on the skin commonly affecting knees, elbows, and scalp).
• If you previously had an adverse reaction to quinine.
• If you have a genetic disorder called glucose-6-phosphate dehydrogenase deficiency.
• If you have a rare disease called porphyria that affects metabolism.
• If you have an inactive chronic hepatitis B virus infection.
• Hydroxychloroquine may lower blood glucose. Ask your doctor to inform you about symptoms and signs of low blood sugar levels. It may be necessary to monitor blood glucose levels.
• If you have hearing loss.
• Serious skin rashes have been reported with the use of hydroxychloroquine (see section 4, Possible side effects). These rashes often include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, inflamed eyes). These severe skin rashes are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash may progress to widespread blisters and skin peeling. If you experience these skin symptoms, stop taking hydroxychloroquine and contact your doctor immediately.

Before starting treatment with Duplaxil

• Before starting this medicine, your doctor will perform an eye examination to check for any abnormalities. This eye examination must be repeated periodically if the medicine is used long-term, at least every 6 months while taking hydroxychloroquine. If you are over 65 years old, require a high dose (two tablets daily), or have kidney problems, this examination must be performed more frequently. If you experience any vision problems while using this medicine (for example, if you notice reduced visual acuity, changes in color perception, or visual field defects), contact your doctor immediately.
• Hydroxychloroquine may cause disturbances in heart rhythm in some patients. This medicine must be taken with caution if you have congenital QT interval prolongation or a family history of it, acquired QT interval prolongation (seen on ECG, a recording of the heart's electrical activity), heart disorders or history of heart attack (myocardial infarction), or electrolyte imbalance in the blood (especially low levels of potassium or magnesium; see "Other medicines and Duplaxil"). If you experience palpitations or irregular heartbeat during treatment, inform your doctor immediately. The risk of heart problems may increase with higher doses. Therefore, the recommended dose must be followed.
• If you take this medicine for a prolonged period, you will need periodic muscle and tendon examinations. Consult your doctor if you begin to notice muscle or tendon weakness.

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before starting Duplaxil.

Some people treated with Duplaxil may experience mental health problems such as irrational thoughts, anxiety, hallucinations, confusion, or depression, including thoughts of self-harm or suicide, even if they have never had such problems before. If you or people around you notice any of these side effects (see section 4), consult a doctor immediately.

Children

Hydroxychloroquine must not be used in children under 6 years of age and weighing less than 31 kg. Young children are particularly sensitive to the toxic effects of quinolones, so this medicine must be kept out of the reach of children.

Other medicines and Duplaxil

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• Certain medicines used to treat depression (monoamine oxidase inhibitors [MAOIs]) must not be combined with hydroxychloroquine.
• Taking hydroxychloroquine with digoxin (a heart medicine) may lead to a strong and undesirable effect of digoxin.
• Hydroxychloroquine may reduce the effectiveness of the rabies vaccine.
• Hydroxychloroquine may increase the risk of epileptic seizures, especially when used with antimalarial medicines (such as mefloquine). Hydroxychloroquine may also reduce the effectiveness of antiepileptic medicines.
• Hydroxychloroquine may enhance the effect of certain diabetes medicines (such as insulin or metformin) on blood glucose. Therefore, it may be necessary to reduce the dose of insulin or other antidiabetic medicines.
• Inform your doctor if you are taking any medicine known to affect heart rhythm, including medicines used to treat heart rhythm disorders (antiarrhythmics), depression (tricyclic antidepressants), mental disorders (antipsychotics), bacterial infections, or malaria (e.g., halofantrine).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will advise you whether this medicine is suitable for you.

Pregnancy

Do not use Duplaxil during pregnancy at high daily doses unless your doctor tells you it is necessary because the risk of stopping treatment is greater than the potential risks to the fetus.

Hydroxychloroquine may be associated with a small increased risk of major congenital malformations.

Breastfeeding

This medicine is excreted in breast milk. There are insufficient data on the effects of hydroxychloroquine in newborns/infants. Depending on the condition and duration of treatment, your doctor will decide whether you can use this medicine while breastfeeding. When taking this medicine once a week, as for malaria prevention, breastfeeding does not need to be interrupted. However, this dose is insufficient to prevent malaria in the infant.

Driving and using machines

You may experience eye problems and dizziness while taking this medicine. If these occur, do not drive or operate tools or machinery, and inform your doctor immediately.

Duplaxil contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Duplaxil

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. Your doctor will decide your daily dose. If you are unsure, ask your doctor or pharmacist.

How much to take

The recommended dose is:

Adults

Rheumatoid arthritis

Initial dose: 400 mg daily, as a single dose or divided into two doses once daily.

Maintenance dose: 200 mg daily, later possibly 200 mg every other day.

Systemic and discoid lupus erythematosus

Initial dose: 400 mg (as a single dose or divided into two doses) to 600 mg (as a single dose or divided into two or three doses) daily.

Maintenance dose: 200 mg to 400 mg (as a single dose or divided into two doses) daily.

Skin disorders caused by sunlight

Treatment is restricted to periods when you are exposed to high levels of light.

Adults: 400 mg daily, as a single dose or divided into two doses, is usually sufficient.

Malaria prevention

Adults: 400 mg once weekly, on the same day each week. For malaria prevention, treatment should begin one week before entering a malaria-risk area and continue for four weeks after leaving the area.

Treatment of an acute episode of malaria

The dose for an acute episode of malaria depends on the nature of the infection. The total dose consists of up to 2 g administered over a maximum period of three days.

Children

Your doctor will determine the dose based on body weight. The 200 mg tablet is not suitable for children with a body weight below 31 kg.

Renal and hepatic impairment

If you have renal or hepatic impairment, your doctor may prescribe a lower dose.

Duration of treatment

Follow your doctor's instructions regarding the duration of treatment. Your doctor will prescribe the lowest possible dose during long-term treatment with this medicine. When treating joint disorders, the medicine may require several weeks to achieve optimal effect.

How to take this medicine

• Take this medicine orally.
• Swallow the tablets whole after a meal.
• If you are taking this medicine to treat skin conditions sensitive to sunlight, take it only during periods of high light exposure.
• Your doctor will calculate the dose based on your body weight. If you think the effect of the medicine is too weak or too strong, do not change the dose yourself—consult your doctor.
• If you have been taking this medicine for rheumatoid arthritis for a prolonged period (more than 6 months) and feel it is no longer helping, contact your doctor, as treatment discontinuation may be necessary.

If you take more Duplaxil than you should

• If you take more hydroxychloroquine than you should, contact your doctor, the nearest hospital emergency department immediately, or call the Toxicology Information Service at 91 562 04 20. Bring the medicine with you and state the amount ingested.
• This way, the doctor will know what you have taken. The following adverse effects may occur: headache, vision problems, sudden drop in blood pressure, seizures, and heart problems followed by sudden severe breathing difficulties and possibly myocardial infarction. Hydroxychloroquine overdose can be fatal.
• Young children and infants are at particular risk if they accidentally ingest hydroxychloroquine. Take the child to the hospital immediately.

If you forget to take Duplaxil

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.

If you stop taking Duplaxil

Keep taking the medicine until your doctor tells you otherwise. Do not stop taking this medicine just because you feel better. If you stop treatment, your condition may worsen.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking the medicine and seek immediate medical attention at a doctor’s office or hospital if you experience any of the following adverse effects:

Rare adverse effects (may affect up to 1 in 1,000 people)

• Eye problems, including changes in eye color and vision problems such as blurred vision, light sensitivity, or changes in how you perceive colors. If detected early, these effects usually diminish after stopping treatment with this medicine. If these problems are not detected until later, they may persist or even worsen after discontinuing treatment.
• Seizures
• Weakening of the heart muscle (heart failure), leading to breathing difficulties, cough, high blood pressure, swelling, increased heart rate, and low urine output.
• Heart muscle disorder (cardiomyopathy), which may be fatal with prolonged use of high doses (see section 2, "Warnings and precautions").

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Severe skin reactions such as blistering and widespread scaly skin along with high temperature (toxic epidermal necrolysis).
• Blistering or peeling of the skin around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever (Stevens-Johnson syndrome).
• Sudden skin rash with pustules, fever, and increased white blood cell count (acute generalized exanthematous pustulosis, AGEP).

Frequency not known (cannot be estimated from available data)

• Allergic reaction. Signs may include erythematous or nodular rash, difficulty swallowing or breathing, and swelling of the eyelids, lips, face, throat, or tongue (angioedema).

• Feeling weak, tired, faint, dizzy, pale skin, shortness of breath, increased tendency to bruise, and more frequent infections than usual (anemia, aplastic anemia, thrombocytopenia, leucopenia, or agranulocytosis).

• Liver problems that may cause yellowing of the eyes or skin (jaundice).

• Reduction in blood glucose (hypoglycemia); you may feel nervous, agitated, or sweaty.

• Depression or thoughts of self-harm or suicide, hallucinations, nervousness or anxiety, confusion, agitation, difficulty sleeping, euphoria, or overexcitement.

• Severe skin reactions (see section 2, Warnings and precautions), such as:

  • Rash with fever and flu-like symptoms and enlarged lymph nodes. This could be a condition called drug reaction with eosinophilia and systemic symptoms (DRESS).
  • Blisters, widespread scaly skin, pus-filled spots along with fever. This could be a condition called acute generalized exanthematous pustulosis (AGEP).
  • Blisters or skin peeling around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever. This could be a condition called Stevens-Johnson syndrome (SJS).
  • Multiple skin lesions, itchy skin, joint pain, fever, and general malaise. This could be a condition called toxic epidermal necrolysis (TEN).
  • Skin reaction, including painful, raised, plum-colored ulcers, especially on the arms, hands, fingers, face, and neck, which may also be accompanied by fever. This could be a condition called Sweet’s syndrome.

• Liver problems. Symptoms may include general malaise, with or without jaundice (yellowing of the skin and eyes), dark urine, nausea, vomiting, and/or abdominal pain. Rare cases of liver failure (including fatal cases) have been reported.

Other adverse effects associated with hydroxychloroquine sulfate

Common adverse effects (may affect up to 1 in 10 people)

• Decreased appetite (anorexia).

Uncommon adverse effects (may affect up to 1 in 100 people)

• Nausea, diarrhea, and abdominal pain. These symptoms usually resolve after reducing the dose or stopping treatment.
• Skin rash.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Mental disturbances (such as delirium, hallucinations, and mood changes).
• Vomiting (usually resolves after reducing the dose or stopping treatment).
• Reduced bone marrow function (myelosuppression).

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Hearing loss (permanent).
• Skin redness with irregular raised spots (erythema multiforme).
• Long-term treatment with the structurally similar substance chloroquine phosphate may, in very rare cases, lead to reversible phospholipidosis (increased accumulation of intracellular phospholipids), including renal phospholipidosis. Due to structural similarity, this adverse effect may also occur with hydroxychloroquine. In such cases, kidney failure may worsen.

Frequency not known (cannot be estimated from available data)

• Worsening of a red blood cell disorder (porphyria).
• Drowsiness/dizziness (vertigo).
• Nervousness.
• Exaggerated mood changes.
• Ringing in the ears (tinnitus).
• Headache.
• Movement disorders such as muscle stiffness and tremors.
• Retinal abnormalities, visual field disturbances resulting in inability to perceive certain parts of the visual field (with paracentral rings, everything near the center of the visual field may be perceived; with pericentral rings, only the center of the visual field may be perceived), transient blind spots in the visual field, and perception of abnormal colors.
• Corneal abnormalities with clouding or fluid retention. Some changes may not cause symptoms, but visual disturbances such as seeing colored halos, blurred vision, or photophobia may occur. These problems are temporary or improve after stopping treatment.
• Blurred vision due to altered eye focusing. This effect is temporary and improves with dose reduction.
• Changes in heart rhythm (your doctor may assess the heart’s electrical activity using an electrocardiograph).
• Enlargement of both heart chambers (biventricular hypertrophy).
• Intense skin itching (pruritus).
• Changes in skin color inside the nose or mouth, hair loss, or loss of hair color (these symptoms usually resolve after dose reduction or stopping treatment).
• Cases of blistering or nodular rashes.
• Increased sensitivity to light (photosensitivity).
• Skin inflammation with redness and peeling (exfoliative dermatitis).
• Recurrent skin disorder accompanied by scaly, dry rash (psoriasis).
• A rare hypersensitivity reaction (DRESS syndrome) characterized by fever, rash, increased white blood cell count, and associated liver and lung disorders.
• Musculoskeletal disorders. These may reverse after stopping treatment with this medicine, but recovery may take several months (myopathy).
• Muscle disorder affecting nerves as well, leading to weakness (neuromyopathy resulting in progressive weakness).
• Reduction in muscle tissue leading to decreased muscle strength (atrophy).
• Sensory perception disturbances.
• Reduced tendon reflexes.
• Impaired control of limbs due to nerve problems.
• Breathing difficulties.
• Abnormal liver function test results.
• Severe liver failure.
• Allergic reactions such as itchy rash and hives (urticaria).
• Irregular heart rhythms, potentially life-threatening arrhythmias (detected on ECG; see section 2, "Warnings and precautions"). If you accidentally take more hydroxychloroquine than prescribed, inform your doctor immediately. Heart problems causing irregular heartbeats may occur.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Duplaxil

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister or the carton after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duplaxil

• Each tablet contains 200 mg of the active substance, hydroxychloroquine sulfate.
• The other components are monohydrate lactose, corn starch, magnesium stearate (E470b), povidone (E1201), polyvinyl alcohol (E1203), talc (E553b), macrogol, and titanium dioxide (E171).

Appearance of the product and contents of the pack

Duplaxil 200 mg film-coated tablets EFG are white or almost white, peanut-shaped, biconvex, film-coated tablets, marked with "H11" on one side and smooth on the other.

Approximate dimensions are 12.80 ± 0.05 mm × 6.10 ± 0.05 mm.

They are supplied in blisters containing 20, 30, 50, 60, 90 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Gebro Pharma, S.A.
Avenida Tibidabo, 29
08022 Barcelona, Spain

Manufacturer

Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind.
Zona Franca, Barcelona 08040, Spain

Date of the most recent review of this leaflet: December 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)